Clinical trial · Interventional
Efficacy of Probiotic Lactobacillus Crispatus M247 in Promoting High-risk Human Papillomavirus (HR-HPV) Infection Clearance and Modifying Vaginal Microbiota
Evaluation of the Efficacy of Lactobacillus Crispatus M247 Administration in Promoting Clearance of Genital HR-HPV Infection and Modulating the Vaginal Microbiota: A Multicenter, Randomized, Placebo-Controlled, Single-Blind, Longitudinal, Prospective Clinical Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This clinical trial evaluates the efficacy of the probiotic strain Lactobacillus crispatus M247 in promoting the clearance of genital high-risk human papillomavirus (HR-HPV) infection and restoring the balance of the vaginal microbiota. The study adopts a multicenter, randomized, single-blind, longitudinal, prospective design involving HR-HPV-positive patients. Primary outcomes include HR-HPV clearance rates and microbiota composition changes.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Human Papillomavirus Infection | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lactobacillus crispatus M247 (Crispact®) | Dietary Supplement | — | UNRESOLVED |
| Placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Probiotic supplement Lactobacillus crispatus M247 group
- description
- Participants in this group will receive probiotic supplement Lactobacillus crispatus M247 (Crispact®) in stick form, administered orally at a dose of one stick per day for 4 months. Each stick contains 20 billion CFU of L. crispatus M247.
- interventionNames
- Dietary Supplement: Lactobacillus crispatus M247 (Crispact®)
- type
- PLACEBO_COMPARATOR
- label
- Control Group
- description
- Participants in the control group will receive a placebo identical in appearance and packaging to the experimental product, administered orally at a dose of one stick per day for 4 months.
- interventionNames
- Other: Placebo
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 69 Years
Show eligibility criteria text
Inclusion Criteria: * Women aged 18-69 years. * First diagnosis of HR-HPV infection via DNA-HPV screening. * Cytology results showing ASC-US or LSIL. * Negative colposcopy or biopsy (absence of lesions). * Ability to provide written informed consent. Exclusion Criteria: * Prior HPV vaccination. * History of cervical treatments for pre-neoplastic pathology. * Cytology showing HSIL (High-Grade Squamous Intraepithelial Lesion) requiring treatment. * Current treatment with antibiotics, immunomodulatory, or immunosuppressive therapies. * Diagnosed immune system or neoplastic diseases requiring chemotherapy. * Pregnancy, lactation, or planning to become pregnant within 6 months. * Known hypersensitivity to product components.
References
Publications (0)
Data not yet available